FDA: Supplements Containing Hidden Prescription Drugs, What the Label Does Not Tell You but Should
The Food and Drug Administration (FDA) has been warning consumers of the dangers of products that are marketed as dietary supplements, particularly for weight loss, bodybuilding, and male sexual enhancement; many contain hidden prescription drugs. This week, they have issued warnings about what the label does not tell you, but should.
Last Tuesday, the FDA issued warnings about three male sexual enhancement products; the first was “Bullet Proof”. They are urging consumers not to purchase the product, or for those who have already bought the supplement to throw it away, as an FDA laboratory analysis has confirmed it is dangerous.
Bullet Proof is a male sexual enhancement pill touted by the manufactured as a “supplement”, and promises such fountain of youth side effects as increased stamina and endurance and feeling 18 again. Manufactured with natural sounding ingredients like Yi Ye Cao, White Willow Bark, Wheat Grass, and Beet Root, the enhancement appears innocuous enough; however, other ingredients such as the Nitric Oxide Booster should be enough to make one ponder the side effects before swallowing.
While the manufacturer does their part in trying to seduce their target audience with a salacious advertising spiel about sexual desire and satisfaction, they do little in terms of the dangers of the little tested pill other than to offer the warning: Seek immediate medical assistance if erection lasts more than 4 hours. Most men (and some women) have seen this as a challenge, if network television is any indication.
However, the analysis by the FDA proves “Bullet Proof” would make a man anything but, especially those with diabetes, high blood pressure, high cholesterol, or heart disease. According to the FDA, the product contains tadalafil, the same ingredient found in the prescription drug Cialis, used for Erectile Dysfunction (ED). Tadalafil is not declared on “Bullet Proof’s” list of ingredients; it may react with nitrates found in prescription drugs such as nitroglycerin.
The danger of mixing “Bullet Proof” for men taking a nitroglycerin-based prescription is an extreme lowering of blood pressure, according to the FDA. They urge consumers to stop using the product immediately and to throw it away. Any users who have experienced negative effects should see their physician as soon as possible.
“Lightning Rod” was found to contain hydroxythiohomosildenafil, which is structurally similar to sildenafil, the active ingredient in Viagra, given for Erectile Dysfunction (ED). Like “Bullet Proof”, this would be dangerous for men with the same conditions.
The third male sexual enhancement in the analysis this week is “Vicerex”, it was found to contain tadalafil, the same as “Bullet Proof”.
Additionally, all consumers and health care professionals are asked to contact the FDA to report negative reactions relating to the use of the product to the FDA MedWatch Safety Information and Adverse Event Reporting Program.
The FDA has recently identified a developing trend with non-prescription products being classified as dietary supplements; they often contain undeclared ingredients that may be harmful to consumers. Purchasers may digest the products containing unknown amounts of approved prescription drugs, controlled substances, or untested and unstudied pharmaceutically active ingredients that may be contraindicative to their condition or may interact with a product or prescription they are taking.
This is becoming increasingly prominent in products being sold for sexual enhancement, weight loss, and bodybuilding.
If you have “Bullet Proof”, “Lightning Rod”, or “Vicerex”, throw it away and discontinue use.
The FDA recommends using caution when purchasing any supplement, ask your healthcare provide when trying to distinguish between reliable and bogus information, be skeptical of anecdotal testimonials, and if the claims sound too good to be true they probably are.
By Dawn Cranfield
Senior Correspondent/Product Specialist